Kornimate/medical-research-clean huggingface dataset:
pegfilgrastim versus filgrastim after high-dose chemotherapy

Conditions: Hematological Neoplasms; Tumors

Summary: the primary objective of the study is to evaluate the efficacy and the safety of pegfilgrastim versus filgrastim, administered after high-dose chemotherapy and peripheral stem cell reinfusion.

secondary objective is to evaluate the immunological reconstitution after pegfilgrastim and filgrastim.

Eligibility criteria:
inclusion criteria: * patients with hematological neoplasms or solid tumors candidable to high-dose chemotherapy with autologous peripheral stem cell reinfusion * adequate organ function * written informed consent. exclusion criteria: * use of other experimental drugs * active infection

Keywords: high-dose chemotherapy growth factor pegfilgrastim
safety and security evaluation of patients submitted to minimally invasive radical prostatectomy

Conditions: Prostate Cancer

Summary: this project aims to evaluate safety and security of patients submitted to minimally invasive radical prostatectomy, who received discharge from hospital in the same day of the surgery (group i), on the 1st post-surgery day (group ii) and in the 2nd post-surgery day (group iii - control). the specific aims are the evaluation of fail index and factors that influence the permanence in the hospital, the satisfaction of patients, the perception of security of patient, the index of post-discharge complications and the costs related to different times of hospitalization. on randomization, those patients in group i must match the early hospital discharge criteria defined in the study. thus, they will be forwarded to "casa de apoio madre paulina", where will receive nursing care until the next day when, in the morning, will be reevaluated in the ambulatory of urology from barretos cancer hospital. the patients of group ii will be evaluated in the ambulatory in the 2nd post-surgery day, before the discharge. in the group iii (control), the patients will be discharged in the 2nd post-surgery day (routine of barretos cancer hospital). all patients who accept to be enrolled in the study will sign the consent term previously the surgery. at the 10th post-surgery day, in the follow-up, it will be applied the patients' satisfaction with mental health services scale (satis-br) questionnaire and an inventory. the data will be descriptive considering average, standard deviation, minimum and maximum value and quartile to the quantitative variables and frequency tables to the qualitative variables. in order to determine the groups' homogeneity, some sociodemographic and clinical characteristics will be compared. to the qualitative variables, it will be used chi-squared test (of fishers exact test), and to the quantitative variables it will be used variance analysis (or kruskal-wallis test). the patients' satisfaction will be measured using satis-br, which consists in three numeric domains (ranging from 1 to 5). the comparison of each domain among the groups will be performed using anova. then, linear regression will be performed in order to analyze the relationship of the patients' characteristics influencing the satisfaction. the rates of fail, clinical security, security perception and post-discharge complications will be compared among the groups using chi-squared test (of fisher's exact test). there will be considered the significance level of 5%.


Eligibility criteria:
inclusion criteria: * localized prostate cancer * bmi ≤ 35 * specific prostate antigen ≤ 30 ng/ml * gleason score ≤ 7 * hemoglobin ≤ 12g/dl * american society of anesthesiologists score ≤ 2 * absence of psychiatric disease exclusion criteria: * perioperative results with estimated blood loss \> 750 ml * blood transfusion need * operative time \> 4 hours * nausea or vomiting at the discharge * uncontrollable pain at the discharge * postural hypotension

Keywords: prostatectomy patient satisfaction questionnaire
natural history of pain after shoulder arthroplasty conducted with multimodal analgesia

Conditions: TSA; Bruise; Pain, Postoperative

Summary: this study aims to identify the timeline of pain following total shoulder replacement with the goal of developing data for a subsequent randomized trial. the investigators believe that with using hss's current protocol, many patients have postoperative pain that is no worse than their preoperative pain. previous hss anesthesia protocols for total shoulder arthroplasty patients have not formally followed patients past their hospital discharge, and the investigators believe that some patients do experience moderate to severe subacute postoperative pain. therefore, this study's primary outcome is to look at the numeric pain scores at 14 days after surgery. future studies will look at measures of preventing bruising and subsequent pain after shoulder replacement.

this is a pilot study, with the goals of 1. developing data for a subsequent randomized trials 2. describing the pain trajectory after total shoulder arthroplasty given comprehensive multimodal perioperative analgesia 3. gathering preliminary data about which shoulder arthroplasty patients are at high risk for moderate or severe postoperative pain (nrs with movement, pod14, moderate \>= 4- 6; gerbershagen 2011; severe \>= 7-10, krebs 2007) potential factors include fibromyalgia score, catastrophizing score, anxiety/depression score, gender, preoperative opioid use 4. gathering preliminary data on the potential association between the predictors listed in (c) and nrs pain score with movement on pod 14. 5. estimating incidence and severity of postoperative bruising on pod 14

Eligibility criteria:
inclusion criteria: * all patients eligible for the standardized anesthetic for tsa * patients who are capable to provide informed consent and answer questions in english (study involves questionnaires validated in english) * age 18-80 exclusion criteria: * incapable to provide informed consent * contraindications for regional anesthesia (anticoagulation, infection at injection site) * patients undergoing tsa for trauma or rheumatoid arthritis * revision tsa (previous non-tsa surgery is not an exclusion) * conversion of hemiarthroplasty to tsa * planned use of tranexamic acid
breast cancer survivor educational intervention

Conditions: Breast Cancer; Breast Neoplasms; Breast Carcinoma; Breast Cancer Female

Summary: the goal of this study is to test a 6-week virtual education program among black breast cancer survivors. the virtual program includes sessions on physical activity, goal setting, nutrition, sleep, stress, and social connections.

this six-week feasibility study will evaluate a virtual support and education program among up to 15 black female breast cancer survivors. participants will be asked to attend a 90 minute group session once a week for 6 weeks and complete surveys pre and post intervention surveys to ascertain study endpoints. this study is supported by funding from pfizer and in-kind support from the american cancer society, inc.

Eligibility criteria:
inclusion criteria: * female * self-identified black or african american race * age 22-79 * diagnosis of stage i, ii, or iii invasive breast cancer * completed active treatment at least 6 months ago, but within the past five years * speaks english exclusion criteria: * undergoing active treatment (i.e., surgery, chemotherapy, radiation) * undergoing evaluation for suspected recurrence

Keywords: breast cancer breast neoplasms breast carcinoma breast cancer female breast cancer survivor
hypotension prediction with hpi algorithm during decessed-donor kidney transplant (hpi2022)

Conditions: Hypotension During Surgery; Kidney Transplant; Complications

Summary: hpi monitoring and the adoption of therapeutic interventions before hypotension occurs should be ensure a shorter time of intra-operative hypotension (map \< 65 mmhg) during deceased-donor kidney transplant surgery. the control group is represented by patients undergoing the same surgical procedure with hemodynamic monitoring with invasive blood pressure monitoring which represents the gold standard for this surgery. hpi monitoring has not yet been investigated during this surgery.


Eligibility criteria:
inclusion criteria: * first single or double kidney transplant from a cadaveric donor; * asa class iii-iv; * signature of informed consent. exclusion criteria: * patient with atrial fibrillation rhythm or high frequency tachyarrhythmias; * severe valvulopathies; * combined single/double kidney-liver-transplant; * patients in whom the need for monitoring would still be expected advanced, invasive or minimally invasive hemodynamic, regardless of the allocation to the study group; * inclusion in another study.

Keywords: hpi
the impact of immune cell changes during the perioperative period on the prognosis of patients with colorectal cancer

Conditions: Colorectal Cancer

Summary: this is a multi-center, prospective, non-interventional real-world study. in a real-world environment, in line with the current status of the domestic diagnosis and treatment process, and on the premise of not increasing the burden of patients and medical resources, we explore the best indicators for predicting the outcome of patients with clinical research coordinator (crc) after surgery. the inclusion criteria for patients are perioperative patients with crc. real-world data analysis were conducted to determine whether immunization interventions versus non-interventions were able to improve patients' clinical outcomes (os, pfs).


Eligibility criteria:
inclusion criteria: 1. 18-85 years old, regardless of gender; 2. patients with newly diagnosed crc who are planned to undergo surgery (including patients with metastases but still feasible for surgery); 3. patients who have not been diagnosed for the first time and have not received surgical treatment and now planned to undergo surgery(e.g., patients after neoadjuvant radiotherapy and chemotherapy for middle and low rectal cancer). exclusion criteria: 1. patients who refused to sign informed consent; 2. patients complicated with other tumors; 3. pregnant or lactating women; 4. people with a history of psychotropic drug abuse and unable to quit or those with mental disorders; 5. postoperative histopathological examinations for patients with non-crc type; 6. patients who could not be followed up.

Keywords: colorectal cancer immune cells
influences of multivitamin supplementation on health parameters

Conditions: Health Behavior

Summary: in this study the investigator will evaluate whether a liquid multivitamin supplement influences blood and vital parameters. furthermore the investigator will establish the effects on life quality, mood and perception of stress and will characterize changes on immune system.

the double-blind, randomized intervention study is conducted for 12 weeks and includes two groups (placebo versus verum) with same number of participants. the investigator aims to determine the effects of multivitamin supplement on blood and vital parameters which includes blood pressure, pulse, heart rate, variability of heart rate, vitamin d, vitamin b12, folic acid, homocysteine, hba1c. furthermore the investigator will access life quality, mood and perception of stress through the following questionnaire poms, pss-10, sf12 \& sf36. the investigator will evaluate whether the multivitamin supplement changes the frequency of diseases like cold which represents the function of the immune system.

Eligibility criteria:
inclusion criteria: * healthy women and men * age between 30-60 years * employed exclusion criteria: * acute and chronic diseases (including diabetes, inflammatory bowel diseases, dementia, multiple sclerosis) * frequent use of alcohol, drugs or cigarettes (\>5 cigarettes / day) * use of additional supplements * use of medications (e.g. antihypertensive medications, lipid reducers, thyroid medication)
non-invasive diagnostics and monitoring of mrd and clonal evolution in waldenström's macroglobulinemia and in igm-mgus

Conditions: Waldenstrom Macroglobulinemia

Summary: multicenter retrospective and prospective observational study including patients with wm or igm-mgus evaluated at the time of diagnosis and during the disease course using highly sensitive techniques.

multicenter retrospective and prospective observational study including patients with wm or igm-mgus evaluated at the time of diagnosis and during the disease course using highly sensitive techniques such as flow cytometry, real time quantitative pcr (rt-qpcr), digital droplet pcr (dd-pcr) and ngs, in order to: evaluate the mutational status on genomic dna or cell-free dna and compare the results to assess the most reliable source for mutation studies; perform and compare molecular and flow cytometry analyses on bone marrow, peripheral blood (both analyses), plasma and urine samples (only molecular analysis) to assess the best source for diagnosis and mrd monitoring.

Eligibility criteria:
inclusion criteria: * diagnosis of igm monoclonal gammopathy of undetermined significance (ig-mgus) or waldenström's macroglobulinemia (wm) according to criteria established at the second international workshop on waldenström's macroglobulinemia \[1\] * age ≥ 18 years * previously untreated patients (only for the prospective cohort) * symptomatic or asymptomatic disease * subject understands and voluntarily signs an informed consent form approved by an independent ethics committee (iec)/institutional review board (irb) exclusion criteria: * active hbv, hcv or hiv infection (antihbc+ patients with undetectable hbv-dna are eligible to the study)

Keywords: igm monoclonal gammopathy waldenström's macroglobulinemia minimal residual disease clonal evolution
art-based beauty appreciation intervention

Conditions: Young Adults; Sensory Processing Sensitivity

Summary: this study is a randomized controlled trial with an active control condition evaluating the impact of an art-based beauty appreciation (abba) intervention on trait appreciation of beauty as a primary outcome and well-being and psychological distress as secondary outcomes. the central hypothesis is that the primary and secondary outcomes will increase more in the intervention than in the control condition.

this study is a randomized controlled trial with an active control condition evaluating the impact of an art-based beauty appreciation (abba) intervention on trait appreciation of beauty as a primary outcome and well-being and psychological distress as secondary outcomes. these two programs have been designed and validated in a qualitative pilot study as matched in credibility, intensity, and enjoyment. there are three measurement points for primary and secondary outcomes, including (1) enrollment, (2) a post-test after the intervention/control program, and (3) a 4-week follow-up measure. n = 114 participants will be randomized after baseline into either the intervention or control group (n = 57/group). in addition, to investigate perceived mechanisms, barriers, and facilitators, participants will be selected using purposive sampling and invited to a semi-structured interview until data saturation is reached (expected n = 15).

Eligibility criteria:
inclusion criteria: 1. participants must be between 18-28 years of age, 2. indicate that they have a smartphone to support our data collection and program components, 3. have the ability and interest to make a trip to a museum or new location (i.e., new part of the city), (3) be willing to complete short activities every day for two weeks, (4) and be fluent in english, (6) be based in amsterdam, (7) are willing to share postal address to receive materials. exclusion criteria: 1. participants must not currently be in clinical treatment for a mental health disorder, assessed via self-report, or 2. indicate that they are currently experiencing severe psychological symptoms (i.e., depression, suicidal ideation, severe anxiety) via self-report.

Keywords: beauty appreciation well-being mental health young adults active control condition art based intervention
dexamethasone therapy for low back pain

Conditions: Low Back Pain

Summary: the study will evaluate the efficacy of iv dexamethasone in treatment low back pain as an adjunct to analgesics.


Eligibility criteria:
inclusion criteria: * no "red flags" of serious spinal pathology * normal neurological examination * indication for opioid analgesia based on our pain management protocol * no known hypersensitivity to the medication * ability to provide informed consent exclusion criteria: * pregnancy * all others who do not meet inclusion criteria
tolerability of iron therapy in women with aub

Conditions: Iron Deficiency Anemia; Abnormal Uterine Bleeding

Summary: telephone surveys of female patients using liposomally-bound iron and traditional iron sulphate preparations for the management of iron deficiency anemia to determine gastrointestinal tolerability.

1. rationale and background: abnormal uterine bleeding (aub) affects women worldwide. in high income countries, heavy menstrual bleeding (a subset of aub) is the most common cause of iron deficiency (id) and iron deficiency anemia (ida). although estimates vary, it appears that 20-30% of ida is a result of heavy menstrual bleeding. oral iron replacement is a common treatment modality among patients diagnosed with ida. however, traditional oral iron preparations commonly result in significant gastrointestinal side effects due to the metabolism of the complex that the iron is bound to. gastrointestinal side effects related to iron therapy, including: metallic taste, nausea, flatulence, constipation, diarrhea, epigastric distress, vomiting, and melena. therefore, liposomally bound iron is thought to provide a better side effect profile due to avoiding these traditional complexes. in theory, this will lead to higher rates of compliance and treatment efficacy if patients are not experiencing these side effects. although we have limited data on the efficacy of this iron preparation, the literature suggests that other types of liposomally bound medications have similar efficacy as traditional preparations. therefore, we believe that liposomally bound iron will provide an effective and well tolerated option for women suffering from ida secondary to aub. 2. research question and objectives: how does a novel liposomally-bound iron therapy compare to ferrous sulphate in women with anemia secondary to abnormal uterine bleeding? 2a. determine if it has less gastrointestinal side effects than ferrous sulphate 2b. determine if it has similar efficacy to ferrous sulphate in correcting anemia secondary to abnormal uterine bleeding 3. methods: pre-menopausal women, diagnosed with anemia secondary to abnormal uterine bleeding recruitment via physician offices of gynecologists in calgary, ab two treatment arms, n=10 per arm ferrous sulphate compared to treatment arm (liposomally bound iron) baseline hemoglobin prior to iron therapy initiation pre-op hemoglobin to compare efficacy of iron therapy phone interview with patients using standardized, validated questionnaire to collect information regarding gastrointestinal side effects

Eligibility criteria:
inclusion criteria: * diagnosed with iron deficiency secondary to abnormal uterine bleeding exclusion criteria: * postmenopausal, premenarchal and pregnant women are excluded, as they do not have regular uterine bleeding associated with menses.
a phase 1, open-label study to investigate the pharmacokinetics of tralokinumab (cat-354) in adolescents with asthma

Conditions: Asthma

Summary: the pharmacokinetic (pk) profile of tralokinumab (cat-354) will be studied in adolescent subjects with asthma.

interleukin-13 (il-13) is a pleiotropic cytokine that promotes inflammation, airways hyper-responsiveness (directly and through recruitment and activation of inflammatory cells), mucus hypersecretion, airway remodeling via fibrosis, increased immunoglobulin e (ige) synthesis and mast cell activation.tralokinumab (cat-354) is a human immunoglobulin g4 (igg4) anti-il-13 monoclonal antibody that has been shown to potently and specifically neutralize il-13 in preclinical models.this study will evaluate the pk profile of a single dose of tralokinumab administered subcutaneously at a dose of 300 mg in adolescent subjects with asthma to be compared with the pk data from completed studies in adults.

Eligibility criteria:
inclusion criteria: * age 12-17 years (inclusive) * weight greater than (\>) 30 kilogram (kg) * asthma for a minimum of 6 months prior to screening * effective birth control for both male and female participants in line with protocol details. * exclusion criteria: * previously taken tralokinumab (the study drug) * employee of the clinical study site or any other individuals directly involved with the conduct of the study, or immediate family members of such individuals * pregnant or breastfeeding women * current smoker or cessation less than (\<) 3 months prior to screening * known immune deficiency excluding asymptomatic selective immunoglobulin a * history of cancer - hepatitis b, c or human immunodeficiency virus (hiv) positive * any disease which may cause complications whilst taking the study drug.

Keywords: tralokinumab cat-354 asthma
anterior segment changes after phacoemulsification in cataractous eyes with shallow anterior chamber

Conditions: Cataract

Summary: phacoemulsification in shallow anterior chamber is considered to be more hazardous regarding risk of intraoperative and postoperative complications. limited anterior pars plana vitrectomy can be combined with phacoemulsification to deepen the anterior chamber and facilitate surgical steps

phacoemulsification in shallow anterior chamber is considered to be more hazardous regarding risk of intraoperative and postoperative complications. limited anterior pars plana vitrectomy can be combined with phacoemulsification to deepen the anterior chamber and facilitate surgical steps. this study aimed to compare the efficacy of combined phacoemulsification with limited pars plana vitrectomy versus phacoemulsification alone in cases with shallow anterior chamber. methods: 24 eyes were operated on and divided into two groups. twelve eyes underwent combined approach and the other 12 eyes have undergone phacoemulsification only.

Eligibility criteria:
inclusion criteria: * anterior chamber depth of less than 2.8 mm associated with cataract exclusion criteria: * mature cataract * history of previous ocular surgery * posterior segment pathology

Keywords: limited anterior pars plana vitrectomy
a study of varespladib infusion in subjects with sickle cell disease.

Conditions: Sickle Cell Disease; Vaso-occlusive Crisis

Summary: the purpose of this study is to determine the effectiveness of a 001 infusion in preventing acute chest syndrome in sickle cell disease (scd) subjects with vaso-occlusive crisis, fever, and elevated serum c-reactive protein (crp).


Eligibility criteria:
inclusion criteria: * genotypes hb ss, hb sc, sickle β°-thalassemia, sickle β+ -thalassemia * pain consistent with vaso-occlusive crisis (clinical judgment) and not attributable to other causes * serum crp ≥5.0 mg/l at time of screening * fever defined as oral temperature ≥38.0°c at time of screening * age ≥5 years exclusion criteria: * new or suspected new pulmonary infiltrate diagnosed by chest radiography * females who are nursing, pregnant or intend to become pregnant * renal dysfunction defined as a creatinine level \>1.2 mg/dl for subjects aged 18 or less or a creatinine level \>1.5 mg/dl for subjects over the age of 18 * hepatic dysfunction (alanine aminotransferase \[alt\] or aspartate aminotransferase \[ast\] \>3 × upper limit of normal) * acute neurologic dysfunction * any medical condition for which transfusion may be needed imminently, and/or hemoglobin \<5 g/dl * red blood cell transfusion within 30 days prior to screening * parenteral or oral corticosteroid therapy (inhaled steroids acceptable) within 7 days prior to screening

Keywords: scd